Brief Title
Oxidative Stress in Hypobaric Hypoxia
Official Title
Oxidative Stress in Hypobaric Hypoxia and Influence on Vessel-tone Modifying Mediators
Brief Summary
The trial investigates changes in metabolism during high altitude expedition up to 6865m. A mass-spectrometry based platform is used to detect different oxidative stress related metabolites. Symptoms of acute mountain sickness are evaluated and correlated with laboratory parameters.
Detailed Description
Background Altitude related illness, which include acute mountain sickness (AMS), high altitude pulmonary edema (HAPE) and high altitude cerebral edema (HACE), is common in subjects exposed to high altitude during professional or leisure time activities. There are independent risk factors such as: individual susceptibility and rate of ascent. HAPE is a potentially life-threatening complication of high altitude stay, mostly occuring within the first 2-5 days of exposure. Although there is a controversial discussion, excessive hypoxic pulmonary vasoconstriction is thought to be the main trigger for developing HAPE. Beside the controversial discussion if hypobaric hypoxia leads to oxidative stress it is not known whether oxidative stress contributes to AMS or HAPE. Objective The investigators hypothesize that reactive oxygen species are generated during high altitude stay and contribute to the development of acute mountain sickness. Furthermore they would like to describe other changes in metabolic pathways possibly contributing to vessel tone dysregulation. Methods 36 healthy volunteers will examined during an high altitude medical research expedition to Mount Muztagh ata (7549m) in Western China. Acute mountain sickness scores and clinical parameters will be assessed. Metabolomics analysis of more than 390 parameters, using a mass spectrometry-based targeted metabolomic platform, is used to detect systemic oxidative stress and functional impairment of enzymes that require oxidation-sensitive co-factors. Furthermore routine laboratory test will be done, for example CRP, creatinine and interleukines
Study Type
Interventional
Primary Outcome
Number of volunteers with acute mountain sickness
Secondary Outcome
Change from baseline in oxygen saturation in blood
Condition
Hypobaric Hypoxia
Intervention
Hypoxic exposure
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
36
Start Date
March 2005
Completion Date
February 2010
Primary Completion Date
December 2005
Eligibility Criteria
Inclusion Criteria: - healthy - physical fit - mountaineering experience - 18-70 years Exclusion Criteria - any type of disease - regular intake of medicaments - history of high altitude pulmonary edema - severe acute mountain sickness below an altitude of 3500m - any history of high altitude cerebral edema
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Andreas Huber, Prof. Dr. med., ,
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT01436383
Organization ID
KEK 1189
Secondary IDs
SNSF 3200B0-108300
Study Sponsor
University Hospital Inselspital, Berne
Collaborators
Swiss National Science Foundation
Study Sponsor
Andreas Huber, Prof. Dr. med., Study Chair, Center of Laboratory Medicine, Cantonal Hospital Aarau, 5001 Aarau
Verification Date
September 2011